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publicado el 08/03/2022 03:28 pm

Cecmed authorizes conditional sanitary registration of NeuroEpo for mild and moderate Alzheimer's disease.

A conditional sanitary registration of NeuroEpo, for the indication of mild and moderate Alzheimer's disease, has been approved this Tuesday by the Center for State Control of Medicines, Equipment and Medical Devices (CECMED), after evaluating the documentation.

This was reported by Cubadebate, and it specifies that the registration granted will be valid for three years, as of the date of issuance of the registration certificate.

According to the social networks of the Center for Molecular Engineering, the conditionality of the registration of this product is established for the confirmation of the results of a phase III clinical efficacy study, which must be submitted its request for authorization within a period not exceeding six months.

Created by the Center for Molecular Immunology (CIM) in collaboration with other BioCubaFarma institutions, the drug (NeuroEpo) is a nasal formulation of recombinant human erythropoietin (EPO) with low content of sialic acid, an isoform with a composition similar to the natural EPO produced in the central nervous system. Its application is nasal, which makes it very convenient and simple to use.

In statements offered in October 2021 to Granma, Doctor of Science Tania Crombet Ramos, director of Clinical Research at the CIM, explained that between 2017 and 2020 the different phases of clinical trials were carried out with NeuroEpo for the treatment of Alzheimer's disease, whose results showed safety and efficacy, with improvements in the rates of cognitive impairment, and with a tendency to stop the progression of the ailment in the mild and moderate stages.

 

 

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